Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes, pen needle, basal insulin, long-acting insulin
Brief summary
The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or more single daily injections of greater than 40 units of insulin. Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be enrolled so as to allow for pre-specified analysis of this subgroup.
Detailed description
This is an open-label, randomized two period crossover study. Each subject's participation is expected to last about seven weeks and includes a brief enrolment period followed by two consecutive three week treatment periods (Period 1 and Period 2). In Period 1, subjects will use the first assigned study pen needle (either the 4mm Nano or the 8mm Short) to self-administer daily all their pen-based diabetes medications. Upon completion of Period 1, subjects will switch to the alternate pen needle for Period 2. The randomization schedule will determine the order of pen needle use. Blood samples for determination of fasting blood glucose and serum fructosamine concentrations will be collected at baseline (Visit 2) and the end of Period 1 (Visit 3) and Period 2 (Visit 4). Blood samples will be analyzed by a central laboratory.
Interventions
DEVICE4 mm x 32G pen needle (Nano)
The pen needle will be used to administer all pen-based diabetes medications. When using the 4mm Nano pen needle, subjects are directed to hold the pen device at a 90 degree angle and perform the injection with no pinch-up.
DEVICE8mm x 31G pen needle (Short)
The pen needle will be used to administer all pen-based diabetes medications. When using the 8mm Short pen needle, subjects are directed to use the pinch-up technique for injections in the abdomen and thigh, and no pinch-up at other injection sites. Subjects are to hold the pen device at a 90 degree angle.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes mellitus * Have been using a pen device for all diabetes or diabetes-related medications for at least one month prior to screening * Use a pen device to self-administer greater than 40 units of Lantus, Levemir, and/or NPH in one or more single injections. For split doses, at least one of the injections must deliver more than 40 units. * Documented hemoglobin A1c (HbA1c) from 5.5% to 9.5%, inclusive * Self monitor blood glucose at once daily with a memory blood glucose meter, and willing do so at least twice per day for the duration of the study * On a stable diabetes regimen (insulin and non-insulin meds, diet and exercise) for at least 1 month prior to screening * Able to read, write and follow instructions in English
Exclusion criteria
* Current administration of insulin with a pump. * Current use a syringe to inject insulin or any diabetes-related medication * Participation in clinical study BDDC-08-011 or DBC-10-SQUIR05 * History of intravenous drug abuse. * Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Investigator, would place the subject at risk or potentially confound interpretation of the study results (i.e., recent history of ketoacidosis, hypoglycemic unawareness, etc). * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine | 3 weeks per pen needle | The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users. |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment began at three medical research centers in March 2011. Due to slow enrolment, the study was terminated after 9 weeks.
Pre-assignment details
There is no information for this section.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated due to slow enrolment | 18 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 9.45 |
| Region of Enrollment Canada | 5 participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 21 | 6 / 21 | 6 / 21 |
| serious Total, serious adverse events | 1 / 21 | 1 / 21 | 0 / 21 |
Outcome results
Primary
Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine
The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.
Time frame: 3 weeks per pen needle
Population: No analysis was performed. The study was terminated due to slow enrollment. The same endpoint was studied and reported in a similar subject population, including Lantus users, in study DBC-11-SQUIR05(NCT01231984)which had a similar design.